Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q3 FY2019 Earnings Presentation
39 slides from Astellas Pharma's earnings presentation, Jan 31, 2020
Slide 1: Q3/FY2019 Financial Results
Q3/FY2019 FINANCIAL RESULTS ENDED DECEMBER 31, 2019 Naoki Okamura Representative Director, Corporate Executive Vice President, Chief Strategy Officer and Chief Financial Officer Astellas Pharma Inc. January 31, 2020
Slide 2: Cautionary Statement Regarding Forward-Looking Information
CAUTIONARY STATEMENT REGARDING FORWARD- 2 LOOKING INFORMATION In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas Pharma. These st
Slide 3: Agenda
AGENDA 3 I Q3/FY2019 Consolidated Financial Results II Initiatives for Sustainable Growth III Capital Allocation
Slide 4: Q3/FY2019 Financial Results: Summary (Year on Year)
Q3/FY2019 FINANCIAL RESULTS: SUMMARY 4 (YEAR ON YEAR) • Revenue and Core OP decreased overall, while both increased when excluding FX impacts Sales increased in XTANDI and mirabegron, as well as new products XOSPATA and EVENITY, offsetting most of the sales decreases in Vesicare, Tarceva, Symbicort
Slide 5: Q3/FY2019 Financial Results
Q3/FY2019 FINANCIAL RESULTS 5 Change Change (billion yen) Q3/FY18 Q3/FY19 CER growth (amount) (%) Revenue 1,005.0 988.5 -16.5 -1.6% +1.4% Cost of sales 227.7 221.6 -6.1 -2.7% % of revenue 22.7% 22.4% SG&A expenses 355.8 353.6 -2.2 -0.6% R&D expenses 150.0 159.8 +9.8 +6.5% Amortisation of intangible
Slide 6: Sales of Main Products (Year on Year)
SALES OF MAIN PRODUCTS (YEAR ON YEAR) 6 Sales increases in XTANDI, XOSPATA, mirabegron and new products in Japan Change Change (billion yen) Q3/FY18 Q3/FY19 (amount) (%) Revenue 1,005.0 988.5 -16.5 -1.6% US+25.7, ex-US+18.8 XTANDI 253.4 297.9 +44.5 +17.6% M1 CSPC approved in US in Q3 US+7.0, Japan+2
Slide 7: Cost Items (Year on Year)
COST ITEMS (YEAR ON YEAR) 7 Change Cost of sales Slight decrease due to FX impact on elimination of unrealized gain (ratio) % of revenue (-0.2ppt) • Partially offsetting increases in XTANDI US co-promotion fee and launch costs for new products by efficiently managing expenses and SG&A expenses optim
Slide 8: Progress Against FY2019 Forecast
PROGRESS AGAINST FY2019 FORECAST 8 • Business progresses favorably driven by XTANDI, XOSPATA, mirabegron and new products in Japan • Although no changes have been made to FY2019 forecast revised in Oct 2019, one-off cost (Non-core cost: approximately $100M) due to the acquisition of Audentes to be b
Slide 9: Agenda
AGENDA 9 I Q3/FY2019 Consolidated Financial Results II Initiatives for Sustainable Growth III Capital Allocation
Slide 10: Evrenzo: Launched in Japan
EVRENZO: LAUNCHED IN JAPAN 10 Launched as a first-in-class orally administered HIF-PH inhibitor for renal anemia in patients on dialysis • NDA approved based on the four Phase 3 studies in Mechanism of action Japan including a ESA-controlled study that demonstrated non-inferiority to ESA • Anemia is
Slide 11: Padcev: Launched in US
PADCEV: LAUNCHED IN US 11 The first treatment approved by FDA for locally advanced or mUC following treatment with platinum-based chemotherapy and a PD-1/L1 Inhibitor • Breakthrough therapy designation for CPI-pretreated mUC patients was granted by FDA. Rapid development and approval were enabled by
Slide 12: Continued Progress on 6 Post-PoC Projects
CONTINUED PROGRESS ON 6 POST-POC PROJECTS 12 Development advancing as intended in Strategic Plan 2018 Progress since Q2/FY2019 announcement in Oct 2019 Indication P1 P2 P3 Filed Approved enzalutamide M1 castration-sensitive prostate cancer EU, JP US M0 castration-sensitive prostate cancer gilteritin
Slide 13: 6 Post-PoC Projects: Status Update
6 POST-POC PROJECTS: STATUS UPDATE 13 (Underlined: Updates since Q2/FY2019 announcement in Oct 2019) enzalutamide gilteritinib enfortumab vedotin M1 CSPC Earlier-stage acute myeloid mUC, platinum and • Approved in US in Dec 2019, PD-1/L1 inhibitor pretreated leukemia • Approved in US in Dec 2019 (un
Slide 14: Enfortumab Vedotin (EV): Metastatic Urothelial Cancer (mUC)
ENFORTUMAB VEDOTIN (EV): 14 METASTATIC UROTHELIAL CANCER (mUC) Platinum and PD-1/L1 inhibitor pretreated: Approved in US in Dec 2019 (under the Accelerated Approval Program) First line: To start a Phase 3 study in combination with pembrolizumab Platinum or Platinum and mUC patient Previously untreat
Slide 15: Enfortumab Vedotin (EV): Phase 3 Study for mUC First Line
ENFORTUMAB VEDOTIN (EV): 15 PHASE 3 STUDY FOR mUC FIRST LINE • Locally advanced or metastatic urothelial cancer Phase 3 study (EV-302) • Previously untreated • Platinum eligible • Funded by 3 companies; Seattle Genetics, Astellas, and Merck 1:1:1 Randomized, Open-label • Efficacy endpoints: n=1,095
Slide 16: Enfortumab Vedotin (EV): Other Cancers
ENFORTUMAB VEDOTIN (EV): OTHER CANCERS 16 To start a Phase 2 study in other Nectin-4 expressing cancers Tumor types included in Phase 2 multi-cohort Trial HR+/HER2- breast cancer Points for tumor selection Triple negative breast cancer Unmet medical needs Squamous NSCLC Nectin-4 expression1 Non-
Slide 17: Progress in Focus Area Approach (1/2) Genetic Regulation
PROGRESS IN FOCUS AREA APPROACH (1/2) Genetic Regulation 17 “Genetic regulation” added as our Primary Focus, with acquisition of Audentes Primary Focus In-house R&D Asset acquisition through Genetic Immuno- Mitochondria business development Biology Regulation oncology Regeneration ASIM & Blindne
Slide 18: Progress in Focus Area Approach (2/2) Immuno-oncology
PROGRESS IN FOCUS AREA APPROACH (2/2) Immuno-oncology 18 Further strengthen immuno-oncology area especially CAR-cell therapies, with acquisition of Xyphos Biosciences and collaboration with Adaptimmune Xyphos’ technology and pipeline Image of Xyphos technology • CAR-cell therapy-related technology p
Slide 19: Rx+ Program: Going to the Next Level
Rx+™ Program: Going to the next level to establish 19 a solid foundation for business acceleration • Current Stage: Explore Rx+™ business feasibility Sought the new business opportunities widely from the viewpoints of applying our pharmaceutical New medical solutions technologies to new treatment so
Slide 20: Rx+ Story
Rx+ Story™ 20 A world where people can live mentally and physically healthy lives and be true Rx+™ World to themselves through healthcare solutions based on scientific evidence Expand options for Prevent disease onset and Support active living by people with limited Rx+™ Values slow progression by a
Slide 21: Progress in Rx+ Program: Digital Therapeutics
Chronic disease Progress in Rx+™ Program: Digital Therapeutics progression prevention 21 Enter into Strategic Alliance with Welldoc for Digital Therapeutics - Development and commercialization of digital health solutions - • Co-development and co-commercialization of BlueStar® In Japan & other Asi
Slide 22: Agenda
AGENDA 22 I Q3/FY2019 Consolidated Financial Results II Initiatives for Sustainable Growth III Capital Allocation
Slide 23: Capital Allocation
CAPITAL ALLOCATION 23 Top priority is investment for strategic business growth Dividends to be increased continuously based on mid-and long-term growth Share buybacks to be implemented in a flexible manner Business investment Shareholder return Aiming for steady dividend increase Acquisition during
Slide 24: Appendix
APPENDIX
Slide 25: Q3/FY2019: Revenue by Region
Q3/FY2019: REVENUE BY REGION 25 (billion yen) Q3/FY18 Q3/FY19 Change Japan 291.9 276.2 -5.4% United States 321.2 331.9 +3.3% Established Markets 228.9 218.0 -4.8% Greater China 45.1 44.4 -1.5% International 94.6 102.8 +8.7% Established Markets: Europe, Canada, Australia Greater China: China, Hong Ko
Slide 26: Q3/FY2019: Sales of Main Products
Q3/FY2019: SALES OF MAIN PRODUCTS 26 FY19 (billion yen) Q3/FY18 Q3/FY19 Change CER growth Progress forecast XTANDI 253.4 297.9 +17.6% +21.9% 383.9 77.6% XOSPATA 0.6 9.8 - - 13.9 70.2% OAB products 184.3 157.2 -14.7% -12.3% 201.0 78.2% mirabegron 109.9 121.0 +10.1% +13.1% 158.8 76.2% Vesicare 74.4 36
Slide 27: FX Rate (Actual)
FX RATE (ACTUAL) 27 Average rate for the period Currency Q3/FY18 Q3/FY19 change USD 111 yen 109 yen -2 yen EUR 129 yen 121 yen -8 yen Change in closing rate from PY end Currency Q3/FY18 Q3/FY19 USD +5 yen -1 yen EUR -4 yen -2 yen <Impact of exchange rate on financial results> 30.6 billion yen decrea
Slide 28: FY2019 Forecast: FX Sensitivity
FY2019 FCST：FX SENSITIVITY 28 Forecast rates from Q3/FY2019 onwards: 108 USD/yen, 118 EUR/yen Estimated FX sensitivity (Q3 and onward) of FY2019 forecast by 1 yen appreciation* Year-end rate Average rate 1 yen higher than Currency 1 yen higher than assumption assumption Revenue Core OP Core OP USD A
Slide 29: Balance Sheet/Cash Flow Highlights
BALANCE SHEET/CASH FLOW HIGHLIGHTS 29 (billion yen) FY18 end Dec 2019 Total assets 1,897.6 1,989.8 Cash and cash equivalents 311.1 277.6 Total equity attributable to owners 1,258.4 1,317.4 of the parent Equity ratio (%) 66.3% 66.2% (billion yen) Q3/FY18 Q3/FY19 FY18 Cash flows from operating activit
Slide 30: Details of Shareholder Returns
DETAILS OF SHAREHOLDER RETURNS 30 (yen) (billion yen) 40 Dividends per Share* (left axis) Profit** (right axis) 250 2,500 2,000 200 30 150 1,500 20 38 40 100 1,000 10 50 500 0 00 (billion yen) FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 (Forecast) Total dividends 39.3
Slide 31: Filing Opportunities Announced in Strategic Plan
FILING OPPORTUNITIES 31 ANNOUNCED IN STRATEGIC PLAN enzalutamide ✓✓✓: Approved M0 CSPC ✓✓: Filed zolbetuximab ✓: Data obtained, enzalutamide Gastric and gastroesophageal filing under preparation junction adenocarcinoma M1 CSPC (US) ✓✓✓ gilteritinib (EU,JP) ✓✓ AML (Post-HSCT maintenance) enfortumab v
Slide 32: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 32 Phase 1 Phase 2 Phase 3 Filed ASP1235/AGS62P1 zolbetuximab enzalutamide enzalutamide (Pancreatic adenocarcinoma) (M0 CSPC, M1 CSPC: China) (M1 CSPC: EU,JP) ASP8374/PTZ-201 ASP1650 (Testicular cancer) gilteritinib enzalutamide (R/R AML: China, Other AML) (M0 CRPC: China
Slide 33: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 33 Phase 1 entry to approval, since Q2/2019 financial results announcement in Oct 2019 Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval ASP2390 enfortumab enfortumab roxadustat enzalutamide House dust mite-induced vedotin vedotin Renal anemia in Metastatic castr
Slide 34: Enzalutamide: Androgen Receptor Inhibitor
ENZALUTAMIDE: ANDROGEN RECEPTOR INHIBITOR 34 US/EU/JP Definitive Therapy Castration Sensitive Castration-Resistant ARCHES M1 CSPC newly-diagnosed M1 CSPC PREVAIL AFFIRM Initial Surgery recurrent M1 CRPC M1 CRPC Diagnosis Approved and (1st line) (lines 2+) Salvage launched in US Filed in EU & JP Laun
Slide 35: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 35 PASHA (HOVON) PrE0905 (PrECOG) Chemo Maintenance ADMIRAL High- consolidation GOSSAMER intensity induction Maintenance Transplant Salvage therapy chemo MORPHO FLT3 mut+ AML Launched Low-intensity (US, JP, EU) chemo LACEWING Monotherapy vs salvage Relapsed or refractory
Slide 36: Enfortumab Vedotin (EV): Nectin-4 Targeted ADC
ENFORTUMAB VEDOTIN (EV): 36 NECTIN-4 TARGETED ADC Clinical studies in urothelial cancer Metastatic UC, Platinum and PD-1/L1 inhibitor pretreated; FSFT: July 2018 P3: EV-301 n=600 vs. chemotherapy Enrollment completed Locally advanced or metastatic UC, Previously untreated, P3: EV-302 n=1,095 Under p
Slide 37: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: 37 ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY Target: Claudin 18.2 Gastric and gastroesophageal junction • Claudin is a major structural component of tight (GEJ) adenocarcinoma junctions and seals intercellular space in • Target patient population: locally advanced and epithelial sheets met
Slide 38: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 38 US/EU Phase 3 studies: FSFT of all the 3 studies in Aug 2019 2 Pivotal studies Long-term safety study (SKYLIGHT 1, SKYLIGHT 2) (SKYLIGHT 4) Women suffering from moderate to severe Women suffering from VMS VMS associated with menopause * associated with menopa
Slide 39: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE